Transcranial Direct Current Stimulation, Functional Activity, Stroke, RCT

NCT ID: NCT07200661

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2025-01-30

Brief Summary

Stroke patients often experience impaired balance and weight-bearing due to muscle weakness and neurological deficits. Motor rehabilitation is a crucial goal in their recovery, and transcranial direct current stimulation (tDCS) has emerged as a promising therapeutic approach. When combined with motor training, tDCS can enhance walking and balance abilities. However, there is a lack of research exploring the combination of unstable surfaces training, cognitive function, and tDCS for stroke rehabilitation

Detailed Description

Stroke is a leading cause of long-term disability worldwide, often resulting in impaired motor function, reduced walking ability, decreased muscle strength, and cognitive deficits. These limitations contribute to difficulties in activities of daily living, impaired balance, and reduced quality of life. Effective rehabilitation strategies are essential to promote functional recovery and reduce the risk of long-term dependence.

Transcranial direct current stimulation (tDCS) has emerged as a promising non-invasive neuromodulation technique to facilitate cortical excitability and enhance neuroplasticity in individuals with stroke. Anodal stimulation over the lesioned hemisphere has been shown to improve motor performance and cognitive processing, while sham stimulation does not induce comparable effects. Recent studies suggest that combining tDCS with task-specific rehabilitation programs may provide synergistic benefits by simultaneously enhancing neural activation and functional task performance.

Dual-task training, particularly stepping exercises performed on unstable surfaces, has been demonstrated to challenge both motor and cognitive systems simultaneously. This approach targets balance, gait adaptation, and executive function by requiring patients to divide attention between locomotion and cognitive demands. When applied in combination with tDCS, dual-task training may enhance neuroplasticity and strengthen functional outcomes beyond those achieved by conventional training alone.

The present randomized controlled trial is designed to investigate the combined effects of anodal tDCS and dual-task stepping exercise on unstable surfaces in stroke survivors. Participants will be randomized into three groups: (1) active tDCS combined with dual-task stepping, (2) dual-task stepping with sham tDCS, and (3) active tDCS alone. Interventions will be delivered three times per week for four weeks.

Primary outcomes will include measures of functional ability, walking speed, walking endurance, lower limb muscle strength, and cognitive ability. Secondary outcomes will explore the effects of combined stimulation on balance and overall motor recovery. It is hypothesized that participants receiving combined anodal tDCS and dual-task training will demonstrate greater improvements in both motor and cognitive outcomes compared with either intervention alone.

This study will contribute novel evidence to stroke rehabilitation research by addressing the knowledge gap regarding the integration of non-invasive brain stimulation with cognitive-motor dual-task training on unstable surfaces. The findings are expected to provide insights into effective multimodal rehabilitation strategies aimed at improving functional recovery and quality of life in stroke survivors.

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Stroke, Cardiovascular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dual talk with overground walking training + Unstable surface + tDCS

Dual talk with overground walking training + Unstable surface + tDCS Volunteers received 10 min of unstable stepping training and 10 min of dual task overground walking training. After that, they received 20 min of transcranial direct current stimulation.

Note; tDCS: Transcranial direct current stimulation.

Group Type: EXPERIMENTAL

Experimental A tDCS: Transcranial direct current stimulation.

Intervention Type: DEVICE

Group 1: Active tDCS combined with dual-task stepping (Experimental A) Participants in this group will receive anodal tDCS applied over the ipsilesional primary motor cortex (M1) at C3 or C4 (based on the 10-20 EEG system), with the reference electrode positioned over the contralesional supraorbital area. Stimulation will be delivered at an intensity of 2 mA for 20 minutes, During the stimulation period, participants will perform dual-task stepping exercises on unstable surfaces. The stepping program stepping on a foam pad (5 cm thick, 20 cm wide, 12 cm long). Each stepping session lasts 10 minutes and is immediately followed by overground walking at a comfortable speed for 10 meters, while simultaneously performing a cognitive task of counting backwards from 99 to 0. Participants are instructed not to pause or stop while performing the dual task. If they stop for more than 5 seconds, it is considered an error, which will be recorded.

Dual talk with overground walking training + Unstable surface + tDCS (sham)

Volunteers received 10 min of unstable stepping training and 10 min of dual task overground walking training. After that, subjects were placed on the head with no electrical current applied for 20 min.

Note; tDCS: Transcranial direct current stimulation.

Group Type: SHAM_COMPARATOR

Experimental B tDCS: Transcranial direct current stimulation.

Intervention Type: DEVICE

Group 2:This group follows the same stepping and dual-task walking program as Group 1 (stepping on foam pad for 10 minutes, followed by overground walking with backward counting for 10 minutes). However, instead of active stimulation, participants receive sham tDCS.

tDCS only

Participants in this group will receive anodal tDCS only, without any dual-task or stepping training.

Electrode placement and stimulation parameters are identical to Group 1 (anodal over ipsilesional M1, reference over contralesional supraorbital area, 2 mA, 20 minutes, with ramp-up and ramp-down). During stimulation, participants will remain seated and relaxed without additional motor or cognitive tasks.

Total session duration: 20 minutes.

Group Type: EXPERIMENTAL

Experimental C tDCS: Transcranial direct current stimulation.

Intervention Type: DEVICE

Group 3:Participants in this group will receive anodal tDCS only, without any dual-task or stepping training.

Interventions

Experimental A tDCS: Transcranial direct current stimulation.

Group 1: Active tDCS combined with dual-task stepping (Experimental A) Participants in this group will receive anodal tDCS applied over the ipsilesional primary motor cortex (M1) at C3 or C4 (based on the 10-20 EEG system), with the reference electrode positioned over the contralesional supraorbital area. Stimulation will be delivered at an intensity of 2 mA for 20 minutes, During the stimulation period, participants will perform dual-task stepping exercises on unstable surfaces. The stepping program stepping on a foam pad (5 cm thick, 20 cm wide, 12 cm long). Each stepping session lasts 10 minutes and is immediately followed by overground walking at a comfortable speed for 10 meters, while simultaneously performing a cognitive task of counting backwards from 99 to 0. Participants are instructed not to pause or stop while performing the dual task. If they stop for more than 5 seconds, it is considered an error, which will be recorded.

Intervention Type: DEVICE

Experimental B tDCS: Transcranial direct current stimulation.

Group 2:This group follows the same stepping and dual-task walking program as Group 1 (stepping on foam pad for 10 minutes, followed by overground walking with backward counting for 10 minutes). However, instead of active stimulation, participants receive sham tDCS.

Intervention Type: DEVICE

Experimental C tDCS: Transcranial direct current stimulation.

Group 3:Participants in this group will receive anodal tDCS only, without any dual-task or stepping training.

Intervention Type: DEVICE

Other Intervention Names

Unstable surface; Sham tDCS; Unstable surface

Eligibility Criteria

Inclusion Criteria

• Volunteers were diagnosed with cerebrovascular disease, aged 18 years and above, both male and female.

1.1.2. Body mass index between 18.5-29.9 kg/m2 1.1.3. No history of falls in the 6 months prior to the study. 1.1.4. Able to follow instructions and consent to participate in the study. 1.1.5. Able to communicate with the researcher and provide information by themselves.

1.1.6. Able to walk continuously for at least 10 meters safely.

Exclusion Criteria

• 1.2.1 Having undergone surgery to insert metal implants in the body, such as pacemakers, deep brain electrodes.

1.2.2 High blood pressure, uncontrolled heart disease, or having underlying diseases, such as osteoarthritis, arthritis, such as gout, rheumatoid arthritis, severe and affecting treatment.

1.2.3 Having a wound on the skull and abnormal sensation. 1.2.4 Having a history of injury or pain in the extremities. At a pain score of more than 5 out of a full score of 10, assessed by (Visual Analog Scale) 1.2.5 There is a condition of the inner ear that is disturbed, affecting balance, such as tinnitus.

1.2.6. There are unresolved vision and hearing problems. 1.3 Criteria for withdrawing volunteers from the research 1.3.1 If a volunteer experiences pain or discomfort during the test, the test will be stopped and the volunteer will be removed from the research immediately.

1.3.2 The volunteer requests to withdraw or is unwilling to continue the research.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Phayao

OTHER

Sponsor Role: lead

Responsible Party

Chonticha Kaewjoho

Lecturer, Department of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chonticha Kaewjoho, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Phayao

Locations

Mar Fah Luang university

Chiang Rai, Chiangrai, Thailand

Narongsak Khamnon

Chiang Rai, Tha Sut, Thailand

Chonticha Kaewjoho

Phayao, , Thailand

Countries

Thailand

Other Identifiers

UPhayaoChonticha-219

Identifier Type: -

Identifier Source: org_study_id